The effect of eight weeks of rehabilitation exercises on rotator cuff's architecture and function after remplissage procedure on hill-sachs defect
Design
reviewing the records and evaluation of patients with Hill-Sachs injury and entering the subjects in the rehabilitation training program. The simple non-random form will be divided into experimental and control groups.
Settings and conduct
After surgery, the condition of the muscle architecture is determined. Functional evaluations (strength, proprioception and range of motion) will be performed and training interventions will be performed. Pre-tests and post-tests include the evaluation of muscle structural changes by the ultrasound device and the range of motion by the Mobi Mod device, proprioception and strength. It will be measured by the Biodex system.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of the patients should be between 23 to 33 years old. Body mass index (BMI) should be less than 25. No previous history of shoulder surgery.
Exclusion criteria before randomization:
Must not have musculoskeletal and metabolic diseases, inability to perform pre-test sections
Intervention groups
patients will first undergo shoulder remplissage surgery and then the samples of this study, which will be randomly divided into Experimental groups and control group.The groups will be evaluated to measure the amount of strength,range of motion and proprioception.then the intervention, specific training program, will be performed to determine the effectiveness of the exercises for eight weeks.
Main outcome variables
Muscle architecture, isokinetic strength, range of motion, proprioception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220420054598N1
Registration date:2022-10-21, 1401/07/29
Registration timing:prospective
Last update:2022-10-21, 1401/07/29
Update count:0
Registration date
2022-10-21, 1401/07/29
Registrant information
Name
Sam Shajarian
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 3413
Email address
s.shajarian@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eight weeks of rehabilitation exercises on rotator cuff's architecture and function after remplissage procedure on hill-sachs defect
Public title
Effect of eight weeks of rehabilitation exercises on rotator cuff's architecture and function after remplissage procedure on hill-sachs defect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of the patients should be between 23 to 33 years old
Body mass index (BMI) should be less than 25
No previous history of shoulder surgery
Exclusion criteria:
Must not have musculoskeletal and metabolic diseases
Inability to perform pre-test sections
Age
From 23 years old to 33 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization,In this method, we should use simple randomization models such as tap or line, using a table of random numbers, or using computer randomization methods, and assign each client to the intervention group, for example, by tossing a coin, tapping and drawing a line, or We control.
Dislocation and sprain of joints and ligaments of shoulder girdle
Primary outcomes
1
Description
Muscle architecture changes
Timepoint
eight weeks
Method of measurement
Ultrasonography & MRI
2
Description
Range of motion
Timepoint
eight weeks
Method of measurement
Mobee Med (for measuring range of motion)
3
Description
Strength
Timepoint
eight weeks
Method of measurement
Biodex System model pro 4 (for measuring strength)
4
Description
Proprioception
Timepoint
eight weeks
Method of measurement
Biodex System model pro 4 (for measuring proprioception)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the experimental group, after reviewing the records and evaluation of patients with Hill-Sachs injuries, 15 patients will be selected by the surgeon to implement the post-operative rehabilitation exercise program, and then by obtaining written informed consent and registering the data collection form of the subjects. including age, sports history, etc., these people will be invited to do the pre-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) and follow the exercise program (for 8 week) and finally the post-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) will be taken.
Category
Rehabilitation
2
Description
Control group: The control group, after examining the records and evaluating the patients with heel-sachs injury, 15 patients by obtaining written informed consent and registering the form to collect the subjects' information, including age, sports history, etc., by surgeon, from These people will be invited to participate in this research. At first, the people did the pre-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) and in these 8 weeks, they just continued with their routine activities. and finally, after 8 weeks, the post-test (measurement of muscle architecture factors, strength, range of motion, and proprioception) will be taken.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Hamidreza Aslani
Street address
Akhtar Orthopedic Center, Azar Dead End, Sharifi Menesh St., Romi Pol,Shariati St.,Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Fax
+98 21 2260 8246
Email
akhtarhospital@gmail.com
Web page address
https://amc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
ۤFariborz Hovanloo
Street address
School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Fax
+98 21 2243 1953
Email
sportscience@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanloo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanloo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanloo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information about the subjects is personal and will not be shared with others.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information except the subjects' personal information.
When the data will become available and for how long
Six months after the results are published.
To whom data/document is available
All researchers.
Under which criteria data/document could be used
The use of research results is unimpeded by acquiring the source.
From where data/document is obtainable
email:s.shajarian@mail.sbu.ac.ir
What processes are involved for a request to access data/document